PO-692-05 MACRO COMPLICATIONS WITH MICRA — PROCEDURAL COMPLICATIONS OF LEADLESS VERSUS TRANSVENOUS PACEMAKERS USING THE NATIONWIDE READMISSION DATABASE (NRD)

Abstract

Procedural complications involving MICRA (leadless pacemaker) according to the Manufacturer and User Facility Device Experience (MAUDE) database were first reported by our group in 2019. Recently published U.S. registry structural heart data has suggested higher procedural complications related in women when compared with men. We reviewed data reported in the Nationwide Readmission Database from 2016-2018 to assess the risk of major adverse events (MAE) by gender in MICRA when compared with single-lead transvenous pacemakers (SL-PPM). To compare major adverse events among Micra and SL-PPM stratified by gender using the Nationwide Readmission Database 2016 - 2018. Data from the 2016-2018 NRD was extracted and aggregated. Micra and SL-PPM were identified using ICD-10 procedure codes. Major adverse events (defined as death, tamponade, cardiac arrest, cardiogenic shock and post-procedural shock) were identified and aggregated. Data were stratified by gender. Statistical analysis was performed using SAS software. Design-adjusted Rao-Scott chi-squared testing was used. 5,100 Micra observations (2,812 male and 2,288 female) were compared with 26,846 SL-PPM observations (14,806 male and 12,040 female). Major adverse events for MICRA when compared with SL-PPM (p<0.001) across all years. No statistically significant differences in MAE based on gender were observed. Major adverse events were higher in MICRA than SL-PPM. There was no statistically significant difference in MAE amongst male versus female patients. Further investigation is needed on the safety and patient selection for Micra devices.